Mode Of Ventilation During Critical IllnEss Pilot Trial

NCT05563779 | Completed Results DMC

• 1 other identifier: 220446
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

Brief Summary

Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Ventilator-free Days (VFDs) to Day 28 After Enrollment

  Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.

  Enrollment to 28 days

Other Outcomes (15)

• Exposure to Assigned Study Mode in First 3 Days (Feasibility Outcome)

  Enrollment to 72 hours

• Adherence to Study Mode in First 3 Days (Feasibility Outcome)

  Enrollment to 72 hours

• Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome)

  Enrollment to 28 days

Study Arms (3)

Volume Control mode

ACTIVE COMPARATOR

During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.

Other: Volume Control mode

Pressure Control mode

ACTIVE COMPARATOR

During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.

Other: Pressure Control mode

Adaptive Pressure Control mode

ACTIVE COMPARATOR

During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.

Other: Adaptive Pressure Control mode

Interventions

Volume Control mode OTHER

Volume Control mode for mechanical ventilation

Volume Control mode

Adaptive Pressure Control mode OTHER

Adaptive Pressure Control mode for mechanical ventilation

Adaptive Pressure Control mode

Pressure Control mode OTHER

Pressure Control mode for mechanical ventilation

Pressure Control mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Receiving mechanical ventilation through an endotracheal tube or tracheostomy
• Admitted to the study ICU

You may not qualify if:

• Patient is pregnant
• Patient is a prisoner
• Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
• Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial. Chest. 2025 Oct;168(4):912-923. doi: 10.1016/j.chest.2025.03.024. Epub 2025 Apr 4.

  PMID: 40189043 DERIVED

• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan T, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, Decoursey B, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD. Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial. CHEST Crit Care. 2024 Mar;2(1):100033. doi: 10.1016/j.chstcc.2023.100033. Epub 2023 Nov 25.

  PMID: 38742219 DERIVED

• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan T, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, Decoursey B, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD. Protocol and statistical analysis plan for the Mode of Ventilation During Critical IllnEss (MODE) trial. medRxiv [Preprint]. 2023 Jul 24:2023.07.21.23292998. doi: 10.1101/2023.07.21.23292998.

  PMID: 37546787 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Kevin P Seitz, MD
• Organization: Vanderbilt University Medical Center

kevin.seitz@vumc.org

615-936-9329

Study Officials

• Kevin P. Seitz, MD, MSc

  Clinical Fellow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observer bias will be minimized by use of objective endpoints collected in duplicate by \[1\] study personnel blinded to group assignment and \[2\] automated data extraction from the electronic health record.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Model Details: In the MODE trial, the entire study ICU will be assigned to a single mode for continuous mandatory ventilation and the ICU will switch between volume control, pressure control, and adaptive pressure control every month in a randomly generated sequence (cluster-crossover).

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: November 1, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of primary trial results and will remain available for at least 5 years.
• Access Criteria: Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator. Even though the final dataset will be stripped of identifiers prior to release for sharing, the inherent link between the period in which the patient was admitted to the study ICU and group assignment in a cluster-crossover trial introduces a significant risk for deductive disclosure of subjects. Thus, we will make the data available to users only under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)